March 31 2020, Dr. Anders Kjellberg posted a new clinical trial on the NIH Clinical Trials website to study the Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19 (COVID-19-HBO). The study is listed as “Not Recruiting Yet,” but has an estimated completion date of December of 2022. Hopefully we will see results before the end of the year. Read the summary of the clinical trial below.
We hypothesize that hyperbaric oxygen (HBO) is safe for patients with COVID-19 and that HBO reduces the inflammatory reaction in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.
Also known as SARS-CoV-2, COVID-19 is declared a pandemic by World Health Organization (WHO). No specific treatment has been successful as of March 2020. Mortality rates in patients that develop ARDS is extremely high, 61.5-90%, almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 is associated with pulmonary edema, rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators have been tried in experimental settings without proven clinical benefits. HBO significantly reduces inflammatory cytokines and and oedema in other clinical settings. HBO has been used for almost a century, nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials show beneficial effects in variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events and extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.
COVID-19 also known as CoV-2 is declared a pandemic by WHO. More than 400 articles have been published and more than 160 clinical trials are registered but no specific treatment has been successful as of March 2020. Antiviral drugs Lopinavir-Ritonavir did not show any significant benefit compared to standard care in a Chinese randomized controlled study with 199 patients. Even though the overall mortality is low (0.2-7.2% the figures from critical care are fearsome. Mortality rates have been reported as high as 90% in patients developing Acute Respiratory Distress Syndrome (ARDS) in early reports from the Wuhan province and more recent reports has reported overall 28-d mortality rates of 61,5% in ICU patients with acute respiratory illness (ALI), almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 differs from other described ARDS with rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators such as Interleukin-6 (IL-6) inhibitors have been tried in experimental settings but no proper clinical trials have proven positive outcome. Hyperbaric oxygen (HBO) significantly reduces inflammatory cytokines including IL-1β, IL-6 and TNF-α through several transcription factors regulating inflammation, including Hypoxia Inducible Factor 1 (HIF-1), Nrf2 and NFkB. Hyperbaric oxygen (HBO) has been used for almost a century, initially for decompression sickness, but it nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials have been conducted on humans for a variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events. The broad and physiological anti-inflammatory effects of HBO shown in extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.
View the Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04327505